Results of a phase III randomized trial of synchronous chemoradiotherapy (CRT) compared to radiotherapy (RT) alone in muscle-invasive bladder cancer (MIBC) (BC2001 CRUK/01/004).

4517 Background: RT is an alternative to cystectomy in patients (pts) with MIBC. Synchronous CRT improves disease control (versus RT alone) in anal and cervix cancers and in one small trial with cisplatin in MIBC. BC2001 assessed efficacy and toxicity of CRT using 5-fluorouracil (5-FU) and mitomycin C (MMC) for pts with MIBC. Methods: Pts with MIBC (pT2-T4a N0 M0) were randomized in a 2x2 factorial design (1:1 allocation ratio stratified by centre and use of neoadjuvant chemotherapy (neoCT)) to CRT vs. RT alone and/or to standard RT vs. reduced high-dose volume RT to tumor. This is the first report of efficacy results of the CRT randomization. The primary endpoint was loco-regional disease-free survival (LRDFS) with pts censored at second primary, metastasis and death. Secondary endpoints included toxicity, quality of life and overall survival (OS). RT was 64Gy / 32 fractions (f) in 6.5 weeks (wks) or 55 Gy / 20f in 4 wks (as per centre policy). CRT was MMC (12mg/m2 i.v. bolus) day 1 of RT and 5-FU contin...

4517背景：对于肌层浸润性膀胱癌（MIBC）患者，放疗（RT）是膀胱切除术的一种替代选择。同步放化疗（CRT）可改善肛门癌和宫颈癌的疾病控制情况（相较于单纯放疗），并且在一项针对MIBC使用顺铂的小型试验中也有此效果。BC2001研究评估了使用5 - 氟尿嘧啶（5 - FU）和丝裂霉素C（MMC）对MIBC患者进行CRT的疗效和毒性。方法：患有MIBC（pT2 - T4a N0 M0）的患者按照2×2析因设计（按中心和新辅助化疗（neoCT）的使用情况分层，分配比例为1∶1）随机分为CRT组与单纯RT组，以及/或者标准放疗组与肿瘤缩小高剂量体积放疗组。这是关于CRT随机分组疗效结果的首次报告。主要终点是局部区域无病生存期（LRDFS），患者在发生第二原发肿瘤、转移和死亡时进行删失。次要终点包括毒性、生活质量和总生存期（OS）。放疗为6.5周内给予64戈瑞/32次分割（f），或4周内给予55戈瑞/20次分割（依据中心政策）。CRT为在放疗第1天给予MMC（12mg/m²静脉推注）以及持续给予5 - FU……